India is home to 1/6th of the world’s population. Although declining, communicable diseases still account for over 25% of the disease burden.
In 2010 India reported highest number of confirmed malaria cases (1 495 817) & deaths (1023) in the South East Asian region and is the highest TB burden country accounting for 1/5th (21%) of global incidence with an estimated incidence of 1.96 million new cases annually along with a relatively high incidence of several other communicable diseases. The Indian government has been engaged in the development and testing of vaccines for these diseases and is highly supportive of efforts in this direction by international organizations, non-profit entities, and the pharmaceutical/biotech industry.
Analysis of data contained in the US FDA and Indian clinical trials database (CTRI) indicate that in April 2012, there were 102 vaccine studies undertaken in India. Important vaccines undergoing various phases of trials include pentavalent /hexavalent (DPT- Hib-HepB/IPV) vaccines (23 trials), Influenza vaccines (17 trials), Rabies and Rotavirus vaccines (8 trials). Other Diseases and pathogens against which these vaccine studies are directed include those for Cholera (2), Tuberculosis (5), Pneumococcus (3),Meningococcus (4), HPV (4), HiB (1), Japanese Encephalitis (4), Typhoid (3), Malaria (1), Hepatitis (2), Polio (6), Measles (2), Rubella (3), Dengue (1), Tetanus (1), Varicella zoster (1), Ovarian cancer (1) and Non-small cell lung cancer (2).
Regulations for the Conduct of Vaccine Studies in India
In India the conduct of clinical trials is governed by Schedule Y of the Drugs and Cosmetics Rules, 1945. Further, the Central Drugs Standard Control Organization (CDSCO) has issued a guidance document for clinical trial and marketing authorization applications concerning biological products. An application for permission to conduct a clinical trial is required to be submitted to the office of the Drugs Controller General of India (DCGI), and is expected to have four sections containing the following details:
A detailed description of the expected contents of each section is given in guidance document # CT/71108 Version 1.1 read together with Schedule Y of the Drugs & Cosmetics Rules. An application for license to import vaccine supplies for the clinical trial can be made together with the application to conduct the clinical trial. Both the applications are generally processed by the office of the DCGI simultaneously and the import license is issued together with the permission to conduct the trial.
In addition to permission from the DCGI, approvals are also required from RCGM (Review Committee on Genetic Modification) / GEAC (Genetic Engineering Approval Committee) for trials with r-DNA products. For products containing genetically modified organisms (as may be the case with vaccines), the import license issued by the DCGI is valid only together with an environmental approval document issued by the GEAC. Therefore, applications must be made to both the agencies simultaneously.
Operational Models for the Conduct of Vaccine Trials
GVK Biosciences (GVK BIO) has conceptualized 3 models for the conduct of vaccine trials in India. The choice of model depends heavily on the study outcomes to be evaluated and the sponsor’s requirements in terms of budget and timelines.
GVK BIO Experience in Vaccine Trials
GVK BIO has experience with hospital-based and CPU-based models. There are 50 GCP-trained and experienced pediatricians on the GVK BIO investigator database that includes 20 investigators who have past or current experience of working with GVK BIO on vaccine trials. Institutional facilities at GVK BIO include two CPUs with a combined strength of 250 beds and access to over 25,000 healthy volunteers.
Hard infrastructure includes temperature controlled GCP-compliant storage facilities and working experience of cold chain distribution using courier services. The GVK BIO Vaccines team has three seasoned Project Managers with direct and intensive experience of managing vaccine studies and 9 motivated monitors with vaccine study monitoring experience.